Combination Chemotherapy Plus Radiation Therapy in Treating Patients With Non-Small Cell Lung Cancer

• Status: Completed
• Trial end date: 2010-01-01
• Target enrollment: 0
• Participant gender: All

Summary

RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. Radiation therapy uses high-energy x-rays to damage tumor cells. Combining chemotherapy and radiation therapy may kill more tumor cells.

PURPOSE: This phase I/II trial is studying the side effects and best dose of radiation therapy when given with combination chemotherapy and to see how well they work in treating patients with non-small cell lung cancer that cannot be surgically removed.

• Phase: Phase 1
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Alliance for Clinical Trials in Oncology
• Collaborator: National Cancer Institute (NCI)
• Treatments: Albumin-Bound Paclitaxel; Carboplatin; Paclitaxel

Criteria

DISEASE CHARACTERISTICS:

• Histologically or cytologically confirmed non-small cell lung cancer (NSCLC)

• Stage I, II, or III NSCLC that is unresectable due to tumor extent or other medical reasons

• Measurable disease

• Tumor must not exceed volume that would require radiation volumes greater than those allowed on this study

• No more than blunting of the costophrenic angle on chest x-ray due to pleural effusions

• No more than small effusions seen on chest CT scan only

• No supraclavicular adenopathy

PATIENT CHARACTERISTICS:

Age:

• 18 and over

Performance status:

• ECOG 0-1

Life expectancy:

• At least 12 weeks

Hematopoietic:

• Absolute neutrophil count at least 1,500/mm^3

• Platelet count at least 100,000/mm^3

Hepatic:

• Total bilirubin no greater than 1.5 times upper limit of normal (ULN) OR

• Direct bilirubin no greater than 1.5 times ULN

• AST no greater than 3 times ULN

Renal:

• Creatinine clearance at least 40 mL/min

Cardiovascular:

• No New York Heart Association class III or IV heart disease

Pulmonary:

• FEV_1 at least 1 L or 35% of predicted

Other:

• No grade 2 or greater peripheral neuropathy

• No weight loss of 10% or more within the past 3 months

• No uncontrolled infection

• No other malignancy within the past 5 years except adequately treated basal cell or squamous cell skin cancer, adequately treated noninvasive carcinoma (carcinoma in situ), or localized prostate cancer

• No other severe underlying disease that would preclude study participation

• Not pregnant or nursing

• Negative pregnancy test

• Fertile patients must use effective contraception

PRIOR CONCURRENT THERAPY:

Biologic:

• No prior biologic therapy for NSCLC

• No concurrent biologic therapy

• No concurrent prophylactic filgrastim (G-CSF)

Chemotherapy:

• No prior chemotherapy for NSCLC

• No other concurrent chemotherapy

Endocrine therapy:

• No prior endocrine therapy for NSCLC

Radiotherapy:

• No prior radiotherapy for NSCLC

Surgery:

• No prior surgery for NSCLC